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510(k) K934623

ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA by Endomedix — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1993
Date Received
September 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

Other clearances by Endomedix

  • K934170 — ENDOMEDIX Y-ADAPTER (January 11, 1994)
  • K930499 — GRASPING FORCEPS FLEXIBLE STONE DISLODGER (August 16, 1993)
  • K930349 — STONE RETRIEVAL BASKET (June 9, 1993)
  • K926004 — ENDOSCOPE AND ACCOSSORIES (February 10, 1993)
  • K922837 — S1500 XENON LIGHT SOURCE (November 3, 1992)
  • K922082 — LAPAROSCOPIC INTRODUCER (August 3, 1992)

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